The Legal Basis for International Research
Including Georgia in a multicentre international clinical trial is a manageable task when several interconnected norms of the Law of Georgia on Drugs and Pharmaceutical Activities are properly accounted for. Article 5¹ of the law sets the general rule for preclinical and clinical research: research is conducted in accordance with the standards and guidelines approved by the relevant Minister, and its start requires a permit. The coordination of an international trial builds its practical questions precisely around this general rule.
The rights of patients and healthy volunteers participating in the research are protected by the legislation of Georgia, and this protection does not vary with the number of countries in which the trial runs simultaneously. Involving a Georgian centre in an international protocol does not release the sponsor from local requirements — on the contrary, it is the local legal framework that determines which data will be valid and which obligations must be performed for the Georgian market.
Research Conducted Under a Foreign Regulator's Control
Article 5¹ attaches decisive importance to the market on which the research is permitted. Under the law, it is permissible in Georgia for a healthy volunteer to undergo a study that is permitted on a market subject to the control of a foreign or international state regulatory body for pharmaceutical products recognised under the legislation of Georgia, and which is conducted on healthy volunteers. This norm allows the coordinator of an international trial to link the involvement of a Georgian centre to the foreign market where the same study is running under the regulator's supervision.
The law also sets a separate condition for clinical research into a pharmacological agent intended as an advanced therapy medicinal product: such research is permissible if the agent is manufactured under a standard of good manufacturing practice recognised by the Government of Georgia, at an enterprise holding the authorisation to manufacture biological medicinal products. When planning international research, this condition must be verified in advance together with the enterprise's authorisation documents.
Sponsor Insurance and Participant Protection
Before the start of a clinical trial, the sponsor — the person, company, institution or organisation responsible for the initiation, management or funding of the research — must secure insurance of the trial's risk and liability for the duration of its conduct. The insurance provides for the reimbursement or compensation of the treatment costs of the participant or participants, to the extent that these costs were incurred in connection with their participation. In a multicentre trial this guarantee remains mandatory for the Georgian participants as well.
Exclusivity of the Research Data
The coordination of international research is directly linked to its results. Article 4¹ of the law protects the scientific and technical information about a registered pharmaceutical product: it is prohibited to use this information for decisions on the registration of the same or a similar product unless the holder of the admission right has consented to such use. It is likewise prohibited for an applicant under the national regime to rely on the trial and research data submitted by another holder without consent.
These rules operate for six years from the first admission of the pharmaceutical product to the market of an EU member state or Georgia. The period may be extended up to seven years if, within the first six years, the holder of the basic permit obtains authorisation for a new therapeutic use of the product that is regarded as having significant clinical advantage compared with existing methods of treatment. Before relying on research data, the expiry of the exclusivity period must therefore always be checked.